BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE

    MDR report key: 3501996 · Received December 2, 2013

    Report

    Report Number
    MW5033215
    Event Type
    Injury
    Date Received
    December 2, 2013
    Date of Event
    April 8, 2011
    Report Date
    December 1, 2013
    Manufacturer
    J&J DEPUY
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2005 HAD BILATERAL HIP REPLACEMENTS USING DE PUY PINNACLE DEVICES. IN 2011, DEVELOPED HIP PAIN, CLICKING ON THE LEFT, PAIN ON RIGHT. MRI IN (B)(6) 2013 REVEALED BILATERAL PSEUDOTUMORS. I WILL REQUIRE REVISION BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623144 DEPUY PINNACLE DEPUY HIP KWA J&J DEPUY
    623148 DEPUY PINNACLE DEPUY HIP KWA J&J DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention